DEVICE: Glaze (D8370180000)
Device Identifier (DI) Information
Glaze
Thinner - 12 mL (1/2 oz)
In Commercial Distribution
01-8000
Taub Products
Thinner - 12 mL (1/2 oz)
In Commercial Distribution
01-8000
Taub Products
Glaze Thinner is used to refill thinner in a bottle of Glaze Liquid, where the thinner has evaporated over time and / or the user wants to change the viscosity and / or create a custom color and / or extend working time and / or clean applicator brush. Glaze contains a translucent acrylic and thinner that gives a gloss coating to provisional and permanent acrylic, and composite restorations. Glaze is quick setting and cures and bonds to all dental resins, including ethyl and methyl methacrylates, bis-acryl resins, polycarbonates, vinyl methacrylate copolymers, resin crowns and laminates, denture base, acrylic denture teeth and composite resins.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
45236 | Temporary dental crown/bridge resin |
A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EBD | Coating, Filling Material, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep away from open flame. See SDS. |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 12 Milliliter |
Device Record Status
40cb7dc3-1709-4a12-92e8-8b9c4605f8db
October 29, 2021
3
October 26, 2016
October 29, 2021
3
October 26, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1.201.798.5353
customerservice@taubdental.com
customerservice@taubdental.com